FOI release

Enquiry, MHRA policy on allegations that an inspector has been deliberately misled

Case reference FOI2026/00921

Received 31 July 2026

Published 17 September 2026

Request

I am writing with a general enquiry about MHRA policy and procedure. This is not a request under the Freedom of Information Act and is not case-specific. I would be grateful if you could tell me, or point me to where the following is published: 1. How MHRA assesses an allegation that a person has concealed information or products from, or otherwise deliberately misled, an MHRA inspector. 2. Whether there is a procedure or threshold governing referral of such allegations from the inspectorate to the Criminal Enforcement Unit. 3. The definition of "for cause inspection" applied by the Agency, and the circumstances in which a for-cause inspection is conducted following receipt of intelligence alleging unlicensed activity. 4. The criteria applied in deciding whether alleged breaches of the Human Medicines Regulations 2012 are addressed through compliance measures rather than enforcement action.

Response

See attached

Documents

• FOI2026_00921 (redacted).pdf (697.1 KB)

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